Approval Is Seen for Use in U.S. Of 5-Year Birth Control Implant

AP

Published: December 7, 1990

WASHINGTON, Dec. 6—
Federal approval is expected soon for a birth control implant for women that would provide protection against pregnancy up to five years, Government and industry officials say.

Approval of the method, Norplant, is seen as one of the most important advances in birth control since oral contraceptives and the intrauterine device. It would be the first long-acting, hormonal contraceptive available in the United States.

In the Norplant method, six silicone capsules, each about the size of a matchstick, are surgically implanted in a woman's upper arm. The capsules contain a contraceptive hormone that is slowly released over time.

The contraceptive's effects are immediately reversed on removal.

Its major side effect is menstrual irregularities, including prolonged periods and spotting between periods.

Norplant contains no new substances. The silicone rubber and the hormone, levonorgestrel, have been used for many years. But the delivery over a long period of time is a new technique.

"It's another major option for American women because it's long acting and yet it's reversible," said Sandra Waldman, a spokeswoman for the Population Council in New York, which began researching the method 24 years ago.

"It's also a good substitute for sterilization for women who have completed their families, but also good for women who cannot use estrogen, IUD's, women who are breast-feeding," she said. "It's a major expansion of options."

A Food and Drug advisory board recommended approval of Norplant in April 1989, saying the method was at least as safe and effective as any other birth control device on the market.

The contraceptive has been approved in 16 countries.

In the United States, it would be marketed by Wyeth-Ayerst Laboratories Inc. in Philadelphia, a division of American Home Products Corporation.